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The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested chemotherapy drugs are as follows:
Cisplatin, 1.0 mg/ml ≥ 240
Cyclophosphamide (Cytoxan), 20.0 mg/ml ≥ 240
Cytarabine, 100 mg/ml ≥ 240
Cytovene, 10 mg/ml ≥ 240
Dacarbazine (DTIC), 10.0 mg/ml ≥ 240
Docetaxel, 10.0 mg/ml ≥ 240
Doxorubicin Hydrochloride, 2.0 mg/ml ≥ 240
Etoposide (Toposar), 20.0 mg/ml ≥ 240
Fluorouracil, 50.0 mg/ml ≥ 240
Ifosfamide, 50.0 mg/ml ≥ 240
Irinotecan Hydrochloride, 20 mg/ml ≥ 240
Mechlorethamine HCI, 1.0 mg/ml ≥ 240
Methotrexate, 25 mg/ml ≥ 240
Mitomycin C, 0.5 mg/ml ≥ 240
Mitoxantrone, 2 mg/ml ≥ 240
Oxaliplatin, 5mg/ml ≥ 240
Paclitaxel (Taxol), 6.0 mg/ml ≥ 240
ThioTEPA 75.8
Vincristine Sulfate, 1.0 mg/ml ≥ 240
Vinorelbine, 10 mg/ml ≥ 240
Low Permeation Time (minutes) 1.7
Carmustine (BCNU), 3.3 mg/ml
Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 1.7 (mins)

Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim, meeting all the requirements of ASTM standards D6319-10 and ASTM D6124-06. The gloves are non-sterile, single-use, disposable devices.

The provided text is a 510(k) summary for "Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim." This document describes the device's characteristics and performance to demonstrate substantial equivalence to a predicate device. It is not an AI/ML device, and therefore several of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable.

Here's the information that can be extracted:

Acceptance Criteria and Device Performance Study for Powder-Free Nitrile Examination Gloves

This device is not an AI/ML device, and thus many of the requested sections related to AI/ML study design are not applicable. The device is a physical medical glove.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the individual tests (e.g., number of gloves tested for each characteristic or drug permeation). The tests were performance-based, carried out according to ASTM standards for physical device properties and chemical resistance.

• Data Provenance: The tests were conducted by Latexx Manufacturing Sdn. Bhd., located in Malaysia. The document doesn't specify if the data itself originated from Malaysia or another country, but the manufacturing site is in Malaysia. The studies are retrospective from the perspective of being submitted for regulatory approval, as they were completed prior to the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This is a physical device, and the "ground truth" is established by performance against pre-defined standardized physical and chemical tests (e.g., ASTM standards for tensile strength, elongation, dimensions, and chemotherapy drug permeation), not by expert interpretation of data.

4. Adjudication Method for the Test Set

N/A. Not applicable for a physical device undergoing standardized mechanical and chemical testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

N/A. This is not an AI/ML diagnostic device; it is a physical medical glove.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

N/A. This is not an AI/ML device. The tests performed are inherent to the material properties and design of the glove.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by standardized laboratory testing procedures defined by international and national standards (e.g., ASTM D6319-10, ASTM D6124-06, ASTM D6978-05, ISO 10993-0:2002E, ASTM-F 720-81, 21 CFR 800.20). These standards define the methodology for measuring characteristics like dimensions, physical properties, biocompatibility, watertight integrity, and resistance to chemotherapy drug permeation.

8. The Sample Size for the Training Set

N/A. This is a physical device, not an AI/ML algorithm that requires a training set. The device itself is manufactured, and its performance is tested against standards.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable for a physical device.

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Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove and Protein Labeling Claim of 50 Micrograms or Les Protein is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove and Protein Labeling Claim of 50 Micrograms or Less Protein is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-051, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Gloves And Protein Labeling Claim of 50 Micrograms or Less Protein":

This document describes a 510(k) premarket notification for a medical device (examination gloves). The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the "study" referenced here is largely non-clinical testing to meet established standards.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for ASTM D3578, or how many rabbits/guinea pigs were used).

• Provenance: The manufacturing country is Malaysia (Latexx Manufacturing Sdn. Bhd., PT 5054, Kamunting Industrial Estate, 34600 Taiping, Perak, Malaysia). The testing described appears to be retrospective as it's a pre-market submission demonstrating compliance with existing standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert consensus for "ground truth" in the typical sense of a diagnostic or interpretive device. The "ground truth" here is adherence to established engineering and biocompatibility standards, and the results of laboratory tests.

4. Adjudication method for the test set

Not applicable. No expert adjudication method (like 2+1, 3+1) is mentioned or relevant for these types of engineering and biocompatibility tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a diagnostic device or an AI-enabled device. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was performed. The device is an examination glove.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device. It is a physical medical device (gloves).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device is based on:

• Established engineering standards: ASTM D 3578-051 (Standard Specification for Rubber Examination Gloves) and 21 CFR 800.20 (dealing with powder on surgeon's gloves and examination gloves).
• Biocompatibility testing results: Primary skin irritation and delayed contact sensitization tests.
• Chemical tests: USP Iodine test for starch.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this type of device.

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Black Colour Powder Free Nitrile Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Black Colour Powder Free Nitrile Rubber Examination Glove as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product code 80LZA (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile rubber compound. They are black in colour and are powder free.

This document describes the acceptance criteria and the study that proves the device meets those criteria for the Black Colour Powder-Free Nitrile Rubber Examination Glove (K034052).

The device is a patient examination glove and is subjected to performance and biocompatibility testing against relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Black Colour Powder-Free Nitrile Rubber Examination Glove are based on ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves. The device's performance is reported to meet all these current specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes used for each test. However, it mentions "Testing performed per ASTM D 6319 - 00a" and "21 CFR 800.20", indicating that typical sample sizes and methodologies prescribed by these standards would have been followed.

The data provenance is from non-clinical tests conducted by the manufacturer, Latexx Manufacturing Sdn. Bhd., located in Malaysia. The testing described is retrospective in the sense that it was performed on finished product samples to demonstrate compliance with standards for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the "ground truth" for this device is established by objective, standardized physical, chemical, and biological tests, not by expert interpretation of data like in medical imaging. The expertise lies in conducting the tests according to the specified ASTM and FDA guidelines and interpreting the quantitative results.

4. Adjudication Method for the Test Set

This is not applicable to this type of device and testing. The evaluation is based on objective measurements and compliance with numerical and qualitative thresholds defined by the standards (ASTM D 6319-00a and 21 CFR 800.20 for biocompatibility). There is no "adjudication" in the sense of reconciling differing expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of complex data, often aided by AI. Patient examination gloves are a Class I medical device and do not involve AI or human interpretation in their intended use.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone performance study as described is not applicable. This device is a physical product (examination glove), not an algorithm or software. Its performance is evaluated through physical, chemical, and biological testing, not through algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Established standards and specifications: Primarily ASTM D 6319-00a for physical properties and defect levels.
• Objective laboratory test results: For biocompatibility (primary skin irritation and sensitization) and powder content (USP iodine test).
• Regulatory compliance: Specifically, 21 CFR 800.20 for biological evaluation.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI or machine learning model, so there is no "training set" in the context of data-driven systems. The term "training set" is usually reserved for machine learning algorithm development.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this device, this question is not applicable.

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Mint Flavour, Blue Colour Powder Free BarrierPro™ Copolymer Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Cleantexx TM Mint Flavour, Blue Colour Powder Free BarrierPro TM Polybutadiene Copolymer Examination Glovesmeets all the current specifications listed under the ASTMSpecification D 6319-00a, Standard Specification for NitrileExamination Gloves for Medical Application. They aremade from BarrierPro TM synthetic copolymer rubber latex, apolybutadiene based copolymer. They are mint flavour,blue in colour, are powder free.

The provided text describes the regulatory clearance of "CLEANTEXX™ MINT FLAVOUR, BLUE COLOUR POWDER FREE BARRIER PRO™ POLYBUTADIENE COPOLYMER EXAMINATION GLOVES". This is a medical device, specifically an examination glove, and the submission is for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new medical diagnosis or treatment through extensive clinical studies like those for AI/ML-based diagnostic devices.

Therefore, many of the requested points are not applicable to this type of device and submission. I will address the relevant points and indicate when information is not provided or applicable.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical tests performed according to recognized standards and methods.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The submission does not specify the exact sample sizes used for each test (e.g., for physical properties, irritation, or sensitization). ASTM standards typically prescribe minimum sample sizes for specific tests.
• Data Provenance: The tests were performed by the manufacturer, LATEXX MANUFACTURING SDN. BHD., located in Malaysia. The tests are non-clinical (laboratory/animal-based) as opposed to human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. For this type of device (examination gloves), ground truth is established through objective, standardized physical, chemical, and biological tests, not through expert human interpretation or consensus like in diagnostic imaging. Biocompatibility testing (irritation/sensitization) involves animal models and laboratory analysis.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically employed in studies where human expert disagreement on interpretation of data is possible and needs resolution (e.g., in medical image reading). The nature of the tests for examination gloves (physical, chemical, animal-based) does not require such adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML diagnostic device, and therefore, MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device is based on objective measurements and observations derived from:

• Standardized test methods (e.g., breaking strength, elongation, dimensions) as specified in ASTM D 6319-00a.
• Laboratory analysis (e.g., USP iodine test for starch).
• Animal test results for biocompatibility (primary skin irritation in rabbits, delayed contact sensitization in guinea pigs).

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device requiring a training set.

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Blue Colour Powder Free Nitrile Rubber Examination Gloves is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Medtexx™ Blue Colour Powder Free Nitrile Rubber Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D 6913-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile rubber compound. They are blue in color and are powder free.

The provided document describes the acceptance criteria and the study conducted for the Medtexx™ Blue Colour Powder Free Nitrile Rubber Examination Gloves.

Here's the breakdown:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the device "meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves" and "Non-clinical laboratory and animal based test data indicate that the powder-free product meets all performance and biocompatibility requirements." However, specific numerical values for physical properties (e.g., tensile strength, elongation, force at break, freedom from holes) are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not explicitly state the sample size used for each specific test within ASTM D 6319-00a. However, it indicates testing was performed per ASTM D 6319-00a. This standard specifies sampling plans for various tests (e.g., visual inspection for defects, physical dimensions, physical properties, leak test).
• Data Provenance:
  • Country of Origin: The test origin is not explicitly stated, but the submitter (Latexx Manufacturing Sdn. Bhd.) is based in Malaysia.
  • Retrospective or Prospective: The testing described for this 510(k) is prospective, as it was conducted to demonstrate substantial equivalence for the new device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the evaluation of examination gloves. The "ground truth" for examination gloves is established through adherence to recognized international standards (ASTM D 6319-00a) for physical properties and validated laboratory test methods for biocompatibility and chemical composition. There are no human "experts" in the sense of medical diagnosticians establishing interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. The assessment involves physical, chemical, and biological testing against predefined scientific criteria, not subjective human interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The phrase "standalone performance" typically refers to the performance of an AI algorithm. This device is a physical product (medical glove) and its performance is evaluated through laboratory and preclinical (animal) tests, not algorithmic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by:

• Accredited laboratory testing and adherence to published, universally accepted industry standards: Specifically, ASTM D 6319-00a for Nitrile Examination Gloves. This standard dictates test methods and acceptable limits for properties like dimensions, physical characteristics (tensile strength, elongation), and freedom from holes.
• Established biological testing protocols: For biocompatibility (primary skin irritation and delayed contact sensitization), validated animal models are used as the ground truth.
• Standardized chemical tests: For powder-free claims, a USP iodine test for starch is used.

8. The sample size for the training set

This is not applicable. The device is a manufactured product, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this device.

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Powdered Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are green in color and are powdered.

The provided document is a 510(k) summary for "POWDERED GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES". This type of device (examination gloves) is a well-established medical product, and its evaluation for regulatory clearance focuses on material properties, performance characteristics (like puncture resistance, tensile strength, and freedom from holes), and biocompatibility, rather than sophisticated signal processing or AI algorithms.

Therefore, many of the typical questions asked for AI/ML-driven medical devices, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone algorithm performance," "training set size," or "number of experts for ground truth," are not applicable to this submission. The device is a physical product, not a software algorithm.

Here's a breakdown of the requested information based on the provided text, with clarifications where questions do not apply:

1. A table of acceptance criteria and the reported device performance

The device is evaluated against the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The 510(k) summary explicitly states: "Gloves meet all the current ASTM D 6319-00a." and "MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00a".

While the specific numerical acceptance criteria from ASTM D 6319-00a are not fully detailed in this 510(k) summary, the document indicates full compliance. ASTM D 6319-00a generally covers criteria such as:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample sizes used for each test within the ASTM D 6319-00a standard. ASTM standards typically define sampling plans (e.g., AQL levels for visual and physical defects), but the specific number of gloves tested is not in this summary.
• Data Provenance: The device manufacturer (Latexx Manufacturing Sdn. Bhd.) is located in Malaysia. The testing was performed according to ASTM D 6319-00a and 21 CFR 800.20 requirements. The details on where the tests were executed (e.g., specific lab location) are not provided. The nature of these tests (e.g., physical property measurements, biocompatibility) is prospective in the sense that they are performed on manufactured product batches to ensure compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The "ground truth" for examination gloves is established by objective physical and chemical testing (e.g., tensile strength machines, water leak tests, chemical analysis, animal biocompatibility studies), not by human expert interpretation in the same way as medical imaging or clinical diagnostic data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are typically used for subjective clinical assessments or interpretations where multiple observers might disagree. The tests for examination gloves are objective, laboratory-based measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This device is an examination glove, not an AI software. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth is established through:

• Standardized physical and mechanical property testing: Per ASTM D 6319-00a (e.g., measurements for tensile strength, elongation, dimensions, leak tests).
• Biocompatibility testing: Conducted using animal models for primary skin irritation (rabbit) and delayed contact sensitization (guinea pig). These are laboratory-derived ground truths based on standardized biological assay results.

8. The sample size for the training set

This question is not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

This question is not applicable. There is no machine learning "training set" for this device.

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Powder Free Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Medtexx™ Powder Free Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are natural white in color and are powder free.

The provided document is a 510(k) summary for "POWDER FREE GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES". It describes the device, its intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the document. The statement "Testing performed per ASTM D 6319 - 00a" implies that appropriate sample sizes as dictated by the standard were used, but the specific numbers are not mentioned.
• Data Provenance: The document states "Testing performed per ASTM D 6319 - 00a" and refers to "laboratory and animal based test data." This indicates the tests were conducted in a controlled environment (laboratory) and involved animal subjects (rabbits and guinea pigs), likely conducted by the manufacturer or a contracted lab. The country of origin of the data is not explicitly stated, but the manufacturer is based in Malaysia. These were non-clinical (pre-market) tests, which are typically prospective in nature for a new device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established by objective engineering and biocompatibility standards (ASTM D 6319-00a and 21 CFR 800.20), not by expert consensus in interpreting images or clinical outcomes.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where human interpretation of medical data is being evaluated, typically for diagnostic devices. For examination gloves, performance is measured against objective standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. An MRMC study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is an examination glove, which does not involve human interpretation or AI assistance in its function.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable. "Standalone" performance generally refers to the performance of an AI algorithm independent of human interaction. Since this device is an examination glove, it does not involve any algorithms.

7. The type of ground truth used:

• The ground truth used is based on established industry standards and regulatory requirements.
  • ASTM Specification D 6319-00a: This standard defines the physical requirements (e.g., dimensions, tensile strength, elongation, freedom from holes) for nitrile examination gloves. The device's performance against these specifications serves as the factual "ground truth" for its physical properties.
  • 21 CFR 800.20: This refers to the FDA's biocompatibility requirements for medical devices. The results from primary skin irritation and delayed contact sensitization tests against these requirements form the biocompatibility "ground truth."
  • USP iodine test: Used to confirm the absence of starch, which is the "ground truth" for being "powder-free."

8. The sample size for the training set:

This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product (examination glove) and does not involve machine learning or AI.

9. How the ground truth for the training set was established:

This information is not applicable, as there is no training set for this device.

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Non-chlorinated Power Free Natural Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of the healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove

The provided text is a 510(k) premarket notification letter from the FDA regarding a Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove. This document does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria.

The letter primarily:

• Confirms the FDA's review of the 510(k) submission (K014087).
• States that the device is substantially equivalent to legally marketed predicate devices.
• Informs the manufacturer that they can market the device subject to general controls.
• Outlines general regulatory compliance requirements.
• Provides contact information for further guidance.
• Includes a separate "Indications for Use" statement, which defines the intended purpose of the device.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used in a study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a regulatory clearance letter, not a performance study report.

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Powder Free Synthetic Rubber Latex (BarrierPro™) Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

CleantexxTM Powder Free Synthetic Rubber Latex Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierProTM synthetic rubber latex, a polybutadiene based copolymer. They are natural white in color and are powder free.

Here's a breakdown of the acceptance criteria and study information for the Cleantexx™ Powder Free Synthetic Rubber Latex Examination Gloves, based on the provided 510(k) summary:

This device is not an AI/ML powered medical device, therefore, many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided summary. The summary indicates "Testing performed per ASTM D 6319 - 00a" and "Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig." The specific number of gloves/animals tested for each of these would be detailed in the full test reports, which are not included here.
• Data Provenance: The manufacturing company is LATEXX MANUFACTURING SDN. BHD. based in Malaysia. The testing would have been conducted by them or a contracted laboratory. The summary does not specify the country of origin of the data beyond the manufacturer's location. The studies are non-clinical (laboratory and animal-based) rather than human observational (retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable as the device is an examination device (gloves) and not an AI/ML or diagnostic device that requires expert ground truth for interpretation of results. The "ground truth" here is defined by meeting specified engineering and biological safety standards (e.g., ASTM standards, USP tests), which are evaluated through objective laboratory measurements and animal studies, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/ML or diagnostic device, there is no need for adjudication of results by experts. The tests performed are objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. No algorithm or AI component is involved in this device.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is based on:

• Standard Specifications: Meeting the performance requirements outlined in ASTM D 6319-00a, which defines physical properties for examination gloves.
• Biocompatibility Standards: Absence of primary skin irritation and delayed contact sensitization, assessed through established animal testing protocols (e.g., USP <88> for irritation, ISO 10993 for sensitization guidance).
• Chemical Purity Standards: Negative result for the presence of starch via the USP iodine test, demonstrating the "powder-free" claim.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore, no training set for an algorithm was used.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set was used, no ground truth needed to be established for it.

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